A Study of MK-8527 in Healthy Adult Participants (MK-8527-013)

A Phase 1 Study to Evaluate the Absorption, Metabolism, and Excretion of [14C]MK-8527 in Healthy Adult Participants

The goal of this study is to learn how [14C]MK-8527 moves through a healthy person's body over time. Researchers will study how [14C]MK-8527 is absorbed by the body, broken down by the body, and how it leaves the body.

Study Overview

• Status: Completed
• Conditions: Healthy
• Intervention / Treatment: Drug: [14C]MK-8527

• Study Type: Interventional
• Enrollment (Actual): 8
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • Wisconsin
    • Madison, Wisconsin, United States, 53704
      • Fortea CRU Madison ( 0001)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Is in good health
• Has a body mass index (BMI) of 18 to 32 kg/m^2

Exclusion Criteria:

• Has a history of cancer
• Has positive tests for hepatitis B surface antigen, hepatitis C antibodies or human immunodeficiency virus

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: [14C]MK-8527; Participants will receive a single oral dose of [14C]MK-8527 on Day 1	Drug: [14C]MK-8527; Oral Dose

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cumulative Percentage of Total Radioactivity Recovered (fe) from Urine and Feces	Urine and fecal samples will be collected to determine the cumulative percentage of radioactivity recovered from both urine and feces.	At designated timepoints (up to approximately 5 weeks post-dose)
Fe from Urine	Urine samples will be collected to determine the percent of total radioactivity recovered from urine.	At designated timepoints (up to approximately 5 weeks post-dose)
Fe from Feces	Fecal samples will be collected to determine the percent of total radioactivity recovered from feces.	At designated timepoints (up to approximately 5 weeks post-dose)
Plasma MK-8527: Area Under the Concentration-Time Curve from Time 0 to 24 Hours Post-dose (AUC0-24)	Plasma samples will be collected to determine the AUC0-24 of MK-8527.	At designated timepoints (up to 24 hours post-dose)
Plasma MK-8527: Maximum Observed Concentration (Cmax)	Plasma samples will be collected to determine the Cmax of MK-8527.	At designated timepoints (up to approximately 14 days post-dose)
Plasma MK-8527: Concentration at 24 Hours Post-dose (C24)	Plasma samples will be collected to determine the C24 of MK-8527.	At designated timepoints (up to 24 hours post-dose)
Plasma MK-8527: Time of the Maximum Observed Concentration (Tmax)	Plasma samples will be collected to determine the Tmax of MK-8527.	At designated timepoints (up to approximately 14 days post-dose)
Plasma Total Radioactivity: AUC0-24	Plasma samples will be collected to determine the AUC0-24 of total radioactivity.	At designated timepoints (up to 24 hours post-dose)
Plasma Total Radioactivity: Cmax	Plasma samples will be collected to determine the Cmax of total radioactivity.	At designated timepoints (up to approximately 5 weeks post-dose)
Plasma Total Radioactivity: C24	Plasma samples will be collected to determine the C24 of total radioactivity.	At designated timepoints (up to 24 hours post-dose)
Plasma Total Radioactivity: Tmax	Plasma samples will be collected to determine the Tmax of total radioactivity.	At designated timepoints (up to approximately 5 weeks post-dose)
Whole Blood Total Radioactivity: AUC0-24	Whole blood samples will be collected to determine the AUC0-24 of total radioactivity.	At designated timepoints (up to 24 hours post-dose)
Whole Blood Total Radioactivity: Cmax	Whole blood samples will be collected to determine the Cmax of total radioactivity.	At designated timepoints (up to approximately 5 weeks post-dose)
Whole Blood Total Radioactivity: C24	Whole blood samples will be collected to determine the C24 of total radioactivity.	At designated timepoints (up to 24 hours post-dose)
Whole blood Total Radioactivity: Tmax	Whole blood samples will be collected to determine the Tmax of total radioactivity.	At designated timepoints (up to approximately 5 weeks post-dose)
Cumulative Amount of Radioactivity Recovered from Urine	Urine samples will be collected to determine the cumulative amount of radioactivity recovered from urine.	At designated timepoints (up to approximately 5 weeks post-dose)
Percent of Total Radioactive Dose Recovered from Urine	Urine samples will be collected to determine the percent of the total radioactive dose recovered from urine.	At designated timepoints (up to approximately 5 weeks post-dose)
Cumulative Amount of Radioactivity Recovered from Feces	Fecal samples will be collected to determine the cumulative amount of radioactivity recovered from feces.	At designated timepoints (up to approximately 5 weeks post-dose)
Percent of Total Radioactive Dose Recovered from Feces	Fecal samples will be collected to determine the percent of the total radioactive dose recovered from feces.	At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Plasma that Represent at least 10% of the Dose of Radioactivity	Plasma samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.	At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Urine that Represent at least 10% of the Dose of Radioactivity	Urine samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.	At designated timepoints (up to approximately 5 weeks post-dose)
Total Number of Metabolites in Feces that Represent at least 10% of the Dose of Radioactivity	Fecal samples will be collected at pre-specified timepoints and used to determine the total number of metabolites that represent at least 10% of the dose of radioactivity. Metabolites will be determined using liquid scintillation and high-resolution mass spectrometry.	At designated timepoints (up to approximately 5 weeks post-dose)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants Who Experience an Adverse Event (AE)	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.	Up to approximately 7 weeks
Number of Participants Who Discontinue the Study Due to an AE	An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the study intervention, whether or not considered related to the study intervention.	Up to approximately 7 weeks

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Study Director: Medical Director, Merck Sharp & Dohme LLC

Publications and helpful links

Helpful Links

• Merck Clinical Trials Information

Study record dates

Study Major Dates

• Study Start (Actual): March 19, 2025
• Primary Completion (Actual): June 4, 2025
• Study Completion (Actual): June 4, 2025

Study Registration Dates

• First Submitted: February 10, 2025
• First Submitted That Met QC Criteria: February 10, 2025
• First Posted (Actual): February 14, 2025

Study Record Updates

• Last Update Posted (Actual): June 11, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Other Study ID Numbers: 8527-013; MK-8527-013 (Other Identifier: MSD)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: https://trialstransparency.msdclinicaltrials.com/pdf/ProcedureAccessClinicalTrialData.pdf

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No